Project Description

An overview of the goals and activities of the Parkinson Pipeline Project with details on the background and each of three main components: 1) consultation to sponsors and regulators, 2) consultation to clinical researchers human subjects, and 3) this database-registry website.

Treatments in Development

Up-to-date information about Parkinson’s disease treatments in clinical phases of development, including information on current clinical trails.


Information about the companies that sponsor research and treatment development. This includes financial information, organizational information and links to sponsor websites, where more details can be found.


A place for patients to find information about participating in clinical trail(s) in an easy to read format including a summary of all current trials in the USA, information on trends in new treatment development, and other helpful information on how to cope with Parkinson’s disease and its effects on our minds, bodies and spirits. (This section is under construction.)

Pipeline Concept

The term “pipeline” describes the process of applying scientific discoveries into more effective treatments for the benefit of patients. The path to curing diseases is like a funnel. Knowledge from basic and applied sciences is fed into the funnel through a wide opening, but the funnel narrows as the science is translated into specific compounds and devices targeted for diseases. The funnel narrows even smaller and stretches out into a long pipeline, as the drugs and devices require lab refinements, animal tests, and then the slow into the laborious process of human trials, regulated and scrutinized by the FDA. In all, the time it takes for a new treatment to go from scientific discovery (the beginning of the funnel) to the public (the end of the pipeline) can be as long as 15 years, or more.

The background section outlines the context and rationale for involvement of patients in the process of evaluation of new treatments

Goals and Program Elements

The goal of the Parkinson Pipeline Project is to facilitate the evaluation and approval of new treatments for Parkinson’s disease (PD). The intention of the Project is to add the unique patient perspective, insight and credibility to the process of the development of safe, effective and timely new treatment. This goal will be attained through collaboration with sponsors and researchers for Investigational New Drugs (IND), or other treatments and with the FDA and the EMEA (European Medical Evaluation Agency). The project has three integrated components:

Activities to Facilitate Clinical Research – Parkinson’s Research Partners

Activities to Facilitate Evaluation and Approval of New Treatments – Patient Advisors to Sponsors and Regulatory Agencies

Website and Database Tracking System on New Treatments in the Pipeline

Parkinson’s Research Partners – Activities to Facilitate Clinical Research

Drawing on our most valuable asset, the people with Parkinson’s disease (PWP), a key component of the project is a network of Parkinson’s Research Partners. These advocates will serve as research ombudsmen in the clinical trial setting to facilitate the process of research and development of new treatments. Telephone counselors and our website bulletin board system will be available to research participants. Drawing on the unique perspective of PWP, these Research Partners will:

1. educate doctors in the community on referrals to research programs,

2. educate/counsel patients and recruit to clinical trials, and

3. educate researchers on patient perspective.

Go to slide presentation of details of the Pipeline components to facilitate clinical research.

Patient Advisors to Sponsors and Regulatory Agencies
Activities to Facilitate Evaluation and Approval of New Treatments

For sponsors of IND’s, we offer PWP Advisors (members of the Parkinson Pipeline Project team) and/or help to establish “Community Advisory Panels” (similar to the AIDS panels) to assist the companies with elements of the design of clinical trials pertinent to our expertise and perspective. These panels will in turn provide a channel for information from the company to the PD population. Our intention is to be a strong independent voice with respect to both the sponsor and the FDA, for the needs of potential research subjects and patients, generally starting as early as possible with FDA and the patient population.

We will also provide independent advice to the FDA, similar to oncology, where advocates are now being recruited to serve as patient advisors in the pre-approval, clinical trial phase of cancer drug development. Patient advisors provide guidance to the FDA and to the drug sponsor on topics such as clinical trial design. More flexible regulatory mechanisms, such as accelerated review and fast tracking procedures, introduced into the FDA process for serious and life threatening illnesses, including PD, can also be influenced by patient advisors and outside patient groups. The Director of the Neuro-Pharmacological Products Division of the FDA has suggested a method to recognize the patient advisors in an independent role utilizing the confidentiality agreements between companies and PWP Advisors.

Independent Patient Advisor Concept. Patient Advisors establish a formal working relationship with the sponsors with a confidentiality agreement that allows the sponsor to share proprietary information under SEC (Security and Exchange Commission) regulations. In order to maintain independence and credibility with all involved parties, no fees will be charged by the Patient Advisor for consultation, other than reimbursement for reasonable expenses. If the confidentiality agreement includes language acknowledging the independence of the Patient Advisor as an advocate for the patient perspective, not as an agent for the sponsor, it allows the FDA to consult independently with the Patient Advisor and gives an added degree of credibility to advocacy positions taken. This concept has been accepted in principal by key officials at FDA, but because it is breaking new ground in the agency, the proposal will undergo a thorough review.

Go to slide presentation of details of the Pipeline components to facilitate regulatory decisions

Database tracking system on new treatments in pipeline
Knowledge and Information Systems Support

To support the goals of the project, an extensive database and tracking system is being created to monitor the development of PD drugs and other new treatments in the pipeline using publicly available information sources. Data are also collected directly from patients and field research partners. The database includes information on the financial status and business environment of the sponsoring organizations, information on the science and history of development of the medication, information on the design of clinical trials and criteria for participation, and is collected on the experiences of trial participants.

Staffed in part by volunteer PWP tracking ‘partners,’ the goal is to make this data base the most complete, up to date source of information on clinical trials for PD. This goal is attainable because, as patients, our trackers are numerous (we extend cooperative membership to all PWP who participate in on-line information sharing), highly motivated, and narrowly focused (on 2 dozen new treatments). Because we solicit data directly from patients and our field staff to clarify the patient perspective on the study, we are well informed to represent the patient’s views to sponsors of clinical trials and regulators (FDA, EMEA). As the most complete source of information on clinical trials, the data base and the communications from it (e.g., website presentations) will be a draw to identify motivated patients who are seeking information on trials as potential research subjects.

Education and communication: The tracking data are utilized to inform partners as well as the public about clinical trials and pipeline treatments. The core program staff will provide initial training and a continuous flow of information to the field. Information will be provided through our secure website ( on such topics as the status of research and science, the development of new treatments, and patients’ reactions to specific clinical trials. As much as possible, basic topics such as the FDA approval process will be packaged into self paced learning modules that can be accessed on-line.

Go to slide presentation of details of the Pipeline components for tracking new treatments.









そのような野菜などの繊維質の食品で構成2-3の食事の代わりに果物、CRAM 小さい 部分を 、4-5の食事の日を食べる。

モーション には、消化を調節するために重要です。特に座っている従業員は、便秘の危険にさらされている。









しばしば便秘あなたの食べ物ヨーグルト等のための医師によって提案されたサラダ、亜麻の 種子に追加します。







揚げ物、赤肉、準備ができた食事、食品、焙煎、非常に甘い食べ物、コーヒー、発泡性飲料を詰める離れて 停止するように食べ物が必要とされている。

























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